Document Detail

Biosimilars in psoriasis: What can we expect?
MedLine Citation:
PMID:  24698590     Owner:  NLM     Status:  In-Data-Review    
Biosimilars are biotechnologically processed drugs whose amino acid sequence is identical to the original biopharmaceutical. They are of considerable clinical, economical, and health care interest. As patents for biologicals used to treat psoriasis expire, biosimilars will become more and more important within the field of dermatology. The patents for the two top-selling drugs (adalimumab and etanercept) will terminate in the next few years. Applications for biosimilars will presumably be submitted to the EMA and the FDA for all patent-free biologicals. Both regulatory bodies have issued guidelines on the assessment of bioequivalence, as well as the benefits and risks of biosimilars. While the preclinical requirements of the FDA and EMA are largely comparable, the formal requirements for clinical bioequivalence, including clinical efficacy and safety, differ markedly. Therefore, from a medical and health care perspective before biosimilars enter the market, specific evidence-based regulatory conditions need to be created and fulfilled. Only then biosimilars can be a less expensive option for a large number of patients, providing them with substances of the same value. Adequate, unequivocal proof of their bioequivalence, quality, and related patient safety should have priority over any ostensible economic benefits.
Marc Alexander Radtke; Matthias Augustin
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG     Volume:  12     ISSN:  1610-0387     ISO Abbreviation:  J Dtsch Dermatol Ges     Publication Date:  2014 Apr 
Date Detail:
Created Date:  2014-04-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101164708     Medline TA:  J Dtsch Dermatol Ges     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  306-12     Citation Subset:  IM    
Copyright Information:
© 2014 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.
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